Actively Recruiting
Time-restricted Feeding to Mitigate Metabolic Impairments During Circadian Misalignment
Led by Colorado State University · Updated on 2025-07-24
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Colorado State University
Lead Sponsor
U
University of Colorado, Denver
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how avoiding food intake during the biological night can reduce the negative effects of circadian misalignment on metabolic health in adults. This study focuses on people who work nonstandard hours such as night shifts, who are at higher risk for obesity and type 2 diabetes due to disrupted sleep and body clocks. The goal is to find behavioral strategies to lower this risk by examining time-restricted feeding as a potential solution. Participants will undergo a randomized crossover study where they experience two conditions during simulated night shift work: one where they eat meals during the biological nighttime and another where they fast during this period, restricting food to daytime hours. Both conditions last about six days, with food intake matched to keep weight stable. The study uses strict controls for diet, activity, and light exposure to measure the effects. Throughout the study, participants will have metabolic assessments including glucose tolerance tests to measure insulin sensitivity and muscle tissue lipid analysis at specific days. Blood samples will be taken to monitor glucose, insulin, and free fatty acid levels over 24 hours. These measurements help researchers understand how time-restricted feeding impacts metabolic function during circadian disruption. The total participation duration varies, with close monitoring during each condition to ensure safety and data accuracy.
CONDITIONS
Brief Title
Countermeasures to Circadian Misalignment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 35 years; men and women; balanced number of women and men
- Body Mass Index (BMI) between 20.0 and 24.9 (normal weight range)
- Physical activity level from inactive to moderate habitual activity
- Habitual sleep duration between 7 and 9.25 hours per night
- Lived at Denver altitude or higher for at least 3 months before study participation
You will not qualify if you...
- Any clinically significant medical, psychiatric, or sleep disorder
- Use of prescribed medications, supplements, or illicit drugs within one month before the study
- History of shift work in the year before study or travel across more than one time zone in the three weeks prior
- Women with prior gynecological pathology, less than one year postpartum, breastfeeding, or pregnant
- Non-English speakers due to lack of translator availability for consent and study communication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 days per condition
Participants undergo a simulated night shift-work protocol lasting approximately 6 days to induce circadian misalignment while remaining awake during the biological night.
1 inpatient stay per condition (two conditions total)
Duration - Approximately 6 days per condition
Participants follow a time-restricted feeding schedule where food intake is limited to a 7-hour daytime period during circadian misalignment to test metabolic effects.
1 inpatient stay per condition (two conditions total)
Duration - Up to 33 days post-condition
Participants complete metabolic assessments including glucose tolerance tests and blood sample collections at specified days after each condition.
4 visits for metabolic testing on Day 3, Day 5, Day 31, and Day 33
Trial Site Locations
Total: 1 location
1
Colorado State University
Fort Collins, Colorado, United States, 80523
Actively Recruiting
Research Team
J
Josiane L Broussard, PhD
E
Ellen Lyon, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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